Ethanol is an extremely potent hepatotoxin and can lead to cirrhosis of the liver upon prolonged exposure. In fact 20% of chronic alcoholics will eventually experience cirrhosis. The process of cirrhosis of the liver involves a series of steps beginning with fatty infiltration which leads to necrosis or cell death, then fibrosis which in turn leads to cirrhosis.
During the initial stage, fatty infiltration, fat which is formed in the liver as a metabolic product of alcohol, begins to accumulate in the liver. This is a transient stage and is reversible upon reduction in ethanol ingestion, however, it will remain and accumulate in the liver upon continued ethanol exposure. When the fatty infiltration gets to a level of 30-40%, the liver becomes enlarged. Following this, some unknown change occurs. The fat begins to leave the liver and is replaced by the abnormal formation of scar tissue in a connective tissue framework. Eventually the scar tissue becomes hard and nodular and this is the stage termed cirrhosis of the liver. When cirrhosis has occurred to approximately 6/7th of the liver, the patient will pass into a stage of hepatic coma and eventually will die.
There are no known cures or treatments for cirrhosis. Once the patient's liver has turned from fatty infiltration to the step of fibrosis, the changes in the liver are irreversible. Current treatment methods involve therapies to relieve some of the symptoms, however, they do not stop the progression. Much study has been devoted to the progression of cirrhosis of the liver with relatively little advance in understanding.
Since there are no effective treatments for liver cirrhosis, it goes without saying there is a need for one. This is particularly true for those addicted to alcohol who by force of the addiction will continue the habit that leads to liver damage. A treatment which would prevent alcohol damage to the liver would be desirable, especially for those whose habits require constant subjection of the liver to alcohol abuse.
In the past, there have been no treatments to prevent the liver damage caused by alcohol. The present invention is therefore fulfilling a need for an effective treatment, in fact the invention virtually prevents the initial stage of cirrhosis from occurring upon exposure to alcohol.
The invention is predicated, at least in part, upon the inventors' knowledge of the metabolic pathways in the body and their experiences with liver function.
It is the object of the present invention to provide a betaine supplement for the diet which will protect the liver against fatty infiltration and advanced liver injury due to ethanol and other hepatotoxins, such as carbontetrachloride.